291 cases of serious adverse events reported

Drug trials on humans in Rajasthan over the last eight years have claimed 95 lives, while 291 persons experienced serious adverse events, according to the State government’s latest deposition before the Supreme Court in an ongoing public interest litigation.

While informing the apex court of the figures, the Rajasthan government has sought to be made part of the overall monitoring and regulatory framework regarding clinical trials in order to protect the health of its citizens, deal with rogue trials and expedite the compensation process.

The 95 deaths include those caused due to the trials, besides deaths due to the natural history of the disease and other unrelated health events.

Four cases of death were deemed fit for compensation by sponsor companies out of which two had been compensated, while the process of compensating the other two was on.

This information was revealed in an affidavit submitted earlier this year by Rajasthan Chief Secretary C.K.Matthew to the Supreme Court, hearing a public interest litigation petition. A committee appointed by the state government came up with these figures after collecting data from 60 principal investigators regarding 213 clinical trials, conducted between 2005-2012.

However, the total number of deaths could be much higher as a total of 326 trials were conducted in Rajasthan during this period.

Some of the drugs for which trials were conducted include Talactoferril, Kremezin, Aliskirel, SU011248 (code name), Prasugrel and Clopidogrel.

In line with responses from other State governments in the case, the Rajasthan government too, has argued for higher powers to the States in the overall monitoring and regulatory framework regarding clinical trials.

“Certainly, the State government needs to be part of the whole process or else how are we to know what steps are to be taken [to deal with rogue trials],” Mr. Matthew told The Hindu .

In its deposition, a copy of which is with The Hindu , the Rajasthan government argued that while the Drugs and Cosmetic Act 1945 was a Central legislation, the State government was primarily responsible for the health of its citizens.

“The data would clearly reveal that sometimes clinical trials have significant adverse impact on the health of patients…existing rules need to be amended accordingly, especially with regard to immediate care for persons suffering SAEs and…with respect to compensation [in case of mortality],” the State government has argued.

It has also called for the strengthening of the existing framework “with sufficient safeguards…with penalties as well as adequate compensation”.

The government argued in favour of an online monitoring system for persons undergoing trials and a proper accreditation system for the selection of principal investigators in which the State government should have a role to play.

Since almost all Ethics Committees overseeing the propriety of the trial process are in-house bodies of sponsor hospitals of which Principal Investigators are also members, the government has called for Ethics Committees to be detached from trial sponsoring sites/institutes.

According to information submitted to the court by the Union Health Secretary in the case, a total of 2,644 deaths and 11,972 SAEs were reported during clinical trials in India between January 2005 and June 2012.

State government seeks higher powers in overall monitoring, regulatory framework